Published User Guides

All Public Reviews

CDISC, in collaboration with the conect4children (c4c) Project, is developing a Pediatrics User Guide, which builds on existing CDISC standards, and will consist of data collection and data tabulation examples for use in pediatric clinical trials.

The c4c project aims to establish a coordinated approach to facilitate the delivery of high-quality regulatory-grade clinical trials in sites across Europe for all paediatric age groups and diseases. c4c is doing this by streamlining clinical trials, facilitating recruitment, educating investigators, and supporting trial design and execution.

Once released, the Pediatrics User Guide will be freely available on the CDISC website for use globally.

The c4c project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777389. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.